AEROFORM® TISSUE EXPANDER SYSTEM, MEDIUM, V3.0

Additional Manufacturer Narrative

DEVICE INVESTIGATION HAS NOT YET CONCLUDED. PRELIMINARY INVESTIGATION SHOWS THAT THIS REPORT WAS NOT AN UNCONTROLLED EXPANSION, BUT INSTEAD A SLOW CLOSING VALVE. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF THE INVESTIGATION.

Description of Event or Problem

ON 24-FEB-2018 IT WAS REPORTED THAT ON (B)(6) 2018 THE LEFT EXPANDER "FILLED UNCONTROLLABLY CAUSING SUBSTANTIAL PAIN AND CHANGE IN BREAST SIZE" DURING EXPANSION AT HOME. THE PATIENT WAS ADMINISTERING ONE DOSE (10 CC) EVERY THREE DAYS ACCORDING TO THE SURGEON'S REPORT. THE PATIENT PRESSED THE DOSAGE CONTROLLER FOR A SINGLE DOSE AND FELT THE EXPANDER CONTINUE EXPANDING. THE SURGEON REPORTS THE PATIENT WAS DIRECTED TO THE ER WHERE THE ER DOCTOR "USED A NEEDLE TO PUNCTURE AND DEFLATE THE DEVICE". THE SURGEON STATES THAT TREATMENT WAS PROCEEDING NORMALLY FOR THIS PATIENT PRIOR TO THIS EVENT. THE PATIENT HAD ATTENDED 6 OR 7 POST-OPERATION VISITS AND NO CONCERNS WERE BROUGHT UP AT THESE TIMES. CHEMOTHERAPY HAD BEEN A PART OF THE PATIENT TREATMENT PLAN, BUT HAD CONCLUDED PRIOR TO THE EVENT.

Additional Manufacturer Narrative

RESULTS: THE INVESTIGATION DETERMINED THAT THE ROOT CAUSE OF THE SLOW VALVE CLOSURE (B)(4) WAS VISCOUS MATERIAL LOCATED INSIDE THE RESERVOIR ASSEMBLY. THE VISCOUS MATERIAL SOURCE WAS ADHESIVE PARTICULATE THAT DISLODGED AND MIGRATED TO THE BACK SIDE OF THE SPRING PAD SUBASSEMBLY, CAUSING THE VALVE TO CLOSE SLOWLY. THE VALVE WAS SLOW TO RETRACT, LEADING TO LONG CLOSURE TIMES AND EXCESS GAS RELEASE. CONCLUSION: VISCOUS MATERIAL, ADHESIVE PARTICULATE, LED TO SLOW CLOSURE OF THE VALVE. THE SOURCE OF THE ADHESIVE PARTICULATE WAS THE HYDREL PAD ADHESIVE. THE PROCESS ERROR THAT WE BELIEVE LED TO THE PRESENCE OF THE VISCOUS MATERIAL HAS NOW BEEN CORRECTED VIA AN ADDITIONAL SCREENING STEP.